Clinical Research Coordinator Health

Location
Michigan, United States
Posted
29 Oct 2018
End of advertisement period
11 Nov 2018
Ref
164569
Contract Type
Permanent
Hours
Full Time

Job Summary

This position will serve as the Clinical Research Coordinator for the Oncology CTSU – Clinic Research Group in the Cancer Center.  The candidate will be responsible for study coordination for patients on clinical trials at the Brighton Center for Specialty Care. This is a new position where working independently and creative problem-solving is welcomed and supported.

We help life-changing research happen.  The science we support is not only interesting, it has a very real potential to positively impact patients and their families. 

Responsibilities*

  • Assist study teams with all aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
  • Coordinates and Facilitates correct timing of study visits and procedures with patients and clinic staff.
  • Under direction of MD - orders study specific lab work and diagnostic procedures. Follows up for abnormal or unexpected findings.
  • May perform ECG or other procedures as needed.
  • Works with research lab services and staff to maintain lab supplies and process samples.
  • Creates source documents for accurate tracking, collection, and recording of experimental data.
  • Accurately collect, maintain, complete electronic and paper case report forms and manage patient and laboratory data for clinical research projects. Will work closely with study monitors and manage site visits. Will help with resolving queries.
  • Provide support and coverage for Brighton research specimen lab including processing and shipping under the direction of lab supervisor.
  • Utilizes critical thinking skills to recognize and solve patient/participant problems including billing issues.
  • Communicates with nurses, IDS, physicians, NP’s/PA’s, phlebotomists and other clinical and research staff to correct/prevent protocol errors. Expeditiously routes AE and SAE information between staff , PI, and oversight agencies as appropriate.
  • Serves as a resource and contact person for active protocols.
  • Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication.
  • Integrates the workflow of many studies running simultaneously.
  • Maintains current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulation,. and maintains knowledge of current ICH and CFR guidelines.
  • Assist in training other staff, Provide coverage for other research staff.
  • Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while maintaining the strictest of confidentiality at all times.

Required Qualifications*

  • Bachelor's Degree or higher preferably in health science or health related field
  • At least two years of experience coordinating Clinical Trials
  • Excellent interpersonal, oral, and written communication skills with exceptional attention to detail
  • Excellent computer skills including proficiency in Microsoft software applications.
  • Excellent organizational skills including the ability to multitask and work well under time constraints and deadlines.
  • Willingness to be flexible in a dynamic working environment.
  • Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.

Desired Qualifications*

  • Master’s Degree
  • Previous experience with Epic, MiChart, Oncology research
  • SOCRA or ACRP certification

Background Screening

The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks.  Background checks will be performed in compliance with the Fair Credit Reporting Act.

Mission Statement

The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future.  The University of Michigan is committed to foster learning, creativity and productivity, and to support the vigorous exchange of ideas and information, not only in the classroom but in the workplace by: 

  • Creating a work environment in which people treat each other with respect and dignity, regardless of roles, responsibilities or differences. 
  • Providing support, direction and resources enabling us to accomplish the responsibilities of our jobs and to reach the goals that are set for professional and personal growth.

Application Deadline

Job openings are posted for a minimum of seven calendar days.  This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.